Tiny pills manufactured as small, round, solid dosage forms comprising a medicinal agent surrounded by a film are known to the medical and to the pharmaceutical arts. The tiny pills known to the prior art are delivered in a conventional manner to a host dispersed in a solid, dry carrier such as a compressed tablet comprising the tiny pills, or a polymeric matrix comprising the tiny pills. In another dosage form the prior art delivered the tiny pills housed in the dry lumen of a conventional capsule.
Tiny or small pills and dosage forms comprising tiny pills in a dry tablet, matrix or dry capsule for dispensing a medicinal agent are known in the following references: Lipowski, G. B. Pat. No. 523,594; Laboratorie de Rechersches, G. B. Pat. No. 1,098,006; Blythe, U.S. Pat. No. 2,738,003; Svedres, U.S. Pat. No. 2,793,979; Wagner, U.S. Pat. No. 2,897,121; Reese, U.S. Pat. No. 2,921,883; Swintosky, U.S. Pat. No. 2,951,792; Press, U.S. Pat. No. 2,953,497; Barry, U.S. Pat. No. 2,996,431; Sheppard, U.S. Pat. No. 3,080,294; Eng, U.S. Pat. No. 3,081,233; Sheppard, U.S. Pat. No. 3,109,775; Neville, U.S. Pat. No. 3,139,383; Gaunt, U.S. Pat. No. 3,328,256; Speiser, U.S. Pat. No. 3,390,050; Chester, U.S. Pat. No. 3,492,397; Raghunathan, U.S. Pat. No. 4,221,778; Urquhart and Theeuwes, U.S. Pat. No. 4,434,153; Urquhart and Theeuwes, U.S. Pat. No. 4,578,075; Urquhart and Theeuwes, U.S. Pat. No. 4,642,233; Urquhart and Theeuwes, U.S. Pat. No. 4,649,043; and Urquhart and Theeuwes, U.S. Pat. No. 4,659,558.
The above presentation teaches that delivery systems have been provided to deliver tiny pills. While those delivery systems provide for delivering the tiny pills, there are serious and inherent short-comings associated with these delivery systems. For example, tiny pills in a tablet may not be available for instant release to the environment of use. Tablets usually are made in a tabletting machine under an applied pressure of a ton or more and this compressive force absorbed by the tablet can seriously delay the release of the tiny pills. Tiny pills dispersed in a polymeric matrix may not be available because they are entrapped in the molecular structure of the polymer. Additionally, well known serious shortcomings are associated with the administration of dry capsules containing tiny pills. Dry capsules are not a conductive means for administering a drug to a patient with a dry or sore throat, they are bulky and hard to swallow, and they do not lend themselves for administering a needed drug to children.
It will be appreciated by those versed in the dispensing art, in view of the above presentation, that a critical need exists for a delivery system for making tiny pills available instantly and continuously to an environment of use. The need exists for providing tiny pills for (a) achieving an early therapeutically effective plasma concentration of drug and for (b) achieving a continuous and therapeutically effective plasma concentration of drug. A delivery system is needed for housing and for providing tiny pills for (c) dispersing the drug in a drug receiving environment for (d) increasing the bioavailability of the drug, (e) for concomitantly decreasing the likelyhood of local irritation of mucosal tissue, and (f) for masking the unpleasant taste of many drugs.